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Effects of Camouflage on the Life Quality of Patients With Vitiligo

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ClinicalTrials.gov Identifier: NCT03540966
Recruitment Status : Unknown
Verified March 2018 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE May 4, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Chinese version of the vitiligo life quality index, VLQI-C [ Time Frame: 4 weeks ]
Chinese version of the vitiligo life quality index, VLQI-C
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • VASI Scoring Criteria [ Time Frame: 4 weeks ]
    VASI=Σall body sites (hand units) × depigmentation
  • Vitiligo European Task Force assessment, VETFa [ Time Frame: 4 weeks ]
    Vitiligo European Task Force assessment, VETFa
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Camouflage on the Life Quality of Patients With Vitiligo
Official Title  ICMJE Development and Psychometric Validation of the Chinese Version of Vitiligo Life Quality Index and Effects of Camouflage on the Life Quality of Patients With Vitiligo: A Randomized Open-label Controlled Study
Brief Summary Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte.The recent therapies to vitiligo are including oral or external glucocorticoids, antioxidants, calcineurin inhibitors or phototherapy. However, long treatment period and unsatisfactory curative effects still exist, which confer long-term psychological burden to patients. As above concerns, it is of great value to explore therapeutic methods that can effectively control disease, improve appearance, relieve patients' pain and improve their quality of life. Current problem is the lack of a vitiligo life quality evaluation scale with Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a vitiligo quality of life scale that is simple, feasible and applicable to China's national conditions. Meanwhile the reliability analysis must be carried out to bring better quality of life assessment tools to patients with vitiligo in China. Previous studies recommended that CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a randomized open-label controlled study to estimate the effects of CapulinTM on QoL of patients with vitiligo.
Detailed Description

Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte. The global incidence is about 0.5-2.0% and prevalence be about 0.8-1.5% in China. Studies showed that almost half of vitiligo patients had developed depigmentation before 20 years old. Lesions involving exposed skin such as face, hand or mucous always make patients feeling embarrassment, so the impaired quality of life (QoL) have greater impact on patients with vitiligo than the disease itself. Besides, Vitiligo is also a psychosomatic disease as its cause stress or depression which can induce dysfunction of endocrine system or immune system in patients, finally resulted in poor curative effects and relapse of the disease which further aggravates stress and depression in patients. Furthermore, traditional Chinese medicine suggested that uneasiness would be a cause of vitiligo as well.

It is of great value to explore therapeutic methods that can effectively control disease, improve appearance, relieve patients' pain and improve their quality of life. Dermatologists of Japan and European suggested that camouflage would be a proper way to improve patients' appearance and it should be an effective supplement to the treatments of vitiligo.

With the transformation of the medical model from a simple biomedical model to a bio-psychological-social medical model, observing changes of lesion in vitiligo may not fully reflect the impact of vitiligo on patients. Therefore, it is necessary to develop some evaluation methods to reflect the impact of vitiligo in patients. Among the various measurement tools, universality scales have a wide range of measurement and can be applied to different groups of people to understand the general health status of the general population. But there are some limitations due to the unspecifically designed for a disease group. When the universal scale is applied to a specific disease, it does not have specificity. Some clinically significant information on quality of life may be omitted, and the QOL cannot be sensitively reflected. The scales in the dermatology area were developed for patients with dermatological diseases and reflect the differences between skin diseases and other system diseases. However, the specificity and sensitivity of specific diseases are still not strong enough.The problem is the lack of a vitiligo life quality evaluation scale with Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a vitiligo quality of life scale that is simple, feasible and applicable to China's national conditions. Meanwhile the reliability analysis must be carried out to bring better quality of life assessment tools to patients with vitiligo in China.

Camouflage is an emerging solution to improve patients' appearance which showing a great potential in treatment of vitiligo. Diagnosis and treatment of vitiligo consensus (2014 edition) made by the dermatological department of the Chinese medical association also suggest that camouflage can be used on exposed skin such as face, neck, hands or feet.The first commercial camouflage agent in China is CapulinTM by 2004, Its formula contains natural plant extracts, moisturizers, emollients and natural pigments. The regimented mechanism is to combine the camouflage with the free protein on the cuticle and finally format the mimic human natural melanin, which is extremely similar to normal skin tone. Previous studies recommended that CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a randomized open-label controlled study to estimate the effects of CapulinTM on QoL of patients with vitiligo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Quality of Life
Intervention  ICMJE
  • Combination Product: CapulinTM
    a kind of camouflage agent
  • Other: Chinese version of the vitiligo life quality index, VLQI-C
    a questionaire designed for patients with vitiligo
Study Arms  ICMJE
  • Experimental: Group A
    complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies plus CapulinTM on-demand treatment period
    Interventions:
    • Combination Product: CapulinTM
    • Other: Chinese version of the vitiligo life quality index, VLQI-C
  • Placebo Comparator: Group B
    complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies on-demand treatment period
    Intervention: Other: Chinese version of the vitiligo life quality index, VLQI-C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 17, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who signed Informed Consent Form;
  • Male or female subjects 18-64 years of age;
  • Clinically confirmed diagnosis of vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology.

Exclusion Criteria:

  • Incompliance with the diagnosis of vitiligo.
  • Patients who had used other camouflage before;
  • Cannot read or understand questionnaire.
  • Patients who had taken antidepressants in the last three months had psychiatric and psycho-related illnesses.;
  • Inability to guarantee taking medications and completing visits as scheduled during the study;
  • Allergic history of any relevant ingredient in the camouflage;
  • The combination of eczema, contact dermatitis, urticaria and other allergic diseases or other serious diseases which are not suitable for the treatment of skin diseases;
  • Serious life-threatening condition such as cancer, autoimmune diseases;
  • Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating;
  • Participating in other clinical studies or within 3 months;
  • Any other condition that the investigator deems unsuitable for entering the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03540966
Other Study ID Numbers  ICMJE XJPF-LCY-V201804
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chunying Li Principal Investigator
PRS Account Xijing Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP